Flumazenil 500micrograms/5ml solution for injection ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Flumazenil

Dostępny od:

Actavis UK Ltd

Kod ATC:

V03AB25

INN (International Nazwa):

Flumazenil

Dawkowanie:

100microgram/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 15010700; GTIN: 5012617022479

Ulotka dla pacjenta

Flumazenil 0.5mg/5ml PIL - UK
item no: AAAC7774
print proof no: 2
origination date: 02.11.11
originated by: SA
revision date: 15.11.11
revised by: sa
dimensions: 148x570
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1.
2.
3.
date sent: 07.11.11
supplier: Synthon
technically app. date: 15.11.11
min pt size:
TECHNICAL APPROVAL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
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IN THIS LEAFLET:
1 WHAT FLUMAZENIL 0.1MG/ML SOLUTION
FOR INJECTION IS AND WHAT IT IS USED FOR
2 BEFORE YOU USE
3 HOW YOU USE
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE
6 FURTHER INFORMATION
1 WHAT FLUMAZENIL 0.1MG/ML SOLUTION FOR INJECTION IS
AND WHAT IT IS USED FOR
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Charakterystyka produktu

OBJECT 1
FLUMAZENIL 0.1 MG/ML SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 28-Jun-2012 | Accord-UK Ltd
1. Name of the medicinal product
Flumazenil 0.1 mg/ml solution for injection.
2. Qualitative and quantitative composition
Each ml contains 0.1 mg flumazenil.
1 ampoule with 5 ml contains 0.5 mg flumazenil.
1 ampoule with 10 ml contains 1 mg flumazenil.
Excipient: each ml of solution contains 3.8 mg sodium.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Flumazenil is indicated for the complete or partial reversal of the
central sedative effects of
benzodiazepines. It may therefore be used in anaesthesia and in the
intensive care in the following
situations:
_In anaesthesia_
- Termination of hypnosedative effects in general anaesthesia induced
and/or maintained with
benzodiazepines in hospitalized patients.
- Reversal of benzodiazepine sedation in short-term diagnostic and
therapeutic procedures in ambulatory
patients and hospitalized patients.
_In intensive care situations_
- For the specific reversal of the central effects of benzodiazepines,
in order to restore spontaneous
respiration.
- For diagnosis and treatment of intoxications or overdose with only
or mainly benzodiazepines.
For the reversal of conscious sedation induced with benzodiazepines in
children > 1 year of age.
4.2 Posology and method of administration
Flumazenil must be administered intravenously by an anaesthesist or
doctor with experience in
anesthesiology. Flumazenil may be administered either undiluted or
diluted.
For dilution, see section 6.6.
It can be administered together with other reanimation measures.
Adults
_Anaesthesia_
The initial dose is 0.2 mg administered i.v. in 15 seconds. If the
desired degree of consciousness is not
obtained within 60 seconds, a second dose of 0.1 mg can be
administered. This may be repeated at 60-
second intervals where necessary, up to a total dose of 1.0 mg. Th